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Use of Noninvasive Brain Stimulation in Parkinson's Disease
This study is currently recruiting participants.
Verified April 2012 by Spaulding Rehabilitation Hospital

First Received on April 20, 2010.   Last Updated on April 9, 2012   History of Changes
Sponsor: Spaulding Rehabilitation Hospital
Information provided by (Responsible Party): Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01113086
  Purpose

The purpose of this research is to determine whether repetitive sessions of transcranial direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive, affective and motor functioning of those with Parkinson's Disease.

In this study we will compare active tDCS with sham tDCS. Each subject will receive two consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and affective tests will be administered throughout the duration of the study.


Condition Intervention Phase
Parkinson's Disease
 Device: Transcranial direct current stimulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Selective Modulation of Cognitive, Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-adjuvant Therapy in Parkinson's Disease.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome
MedlinePlus related topics: Parkinson's Disease Rehabilitation
U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Evidence of improvement in general motor functioning in patients with Parkinson's. [ Time Frame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation) ] [ Designated as safety issue: No ]
    Measured by various indexes, including Unified Parkinson's Disease Rating Scale (UPDRS), Simple Reaction Time, 4-Choice Reaction Time, Purdue Pegboard Test, Finger tapping, walking time, buttoning up and supination-pronation.


Secondary Outcome Measures:
  • Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's. [ Time Frame: after treatment (10 days) and at follow up (1 and 2 months after final stimulation) ] [ Designated as safety issue: No ]
    Will be measured by The Stroop Test, Hooper Visual Organization Test, Digit Span Test, Trail Making Test B.


Estimated Enrollment: 66
Study Start Date: December 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Left active anodal DLPFC
We will place the anodal electrode on the left dorsolateral prefrontal cortex. Stimulation will be given at 2 mA for a total of 20 mins for 10 consecutive sessions (Monday through Friday).
 Device: Transcranial direct current stimulation
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Name: tDCS, direct current stimulation
Experimental: Right active anodal DLPFC
We will place the anodal electrode on the right dorsolateral prefrontal cortex. Stimulation will be given at 2 mA for a total of 20 mins for 10 consecutive sessions (Monday through Friday).
 Device: Transcranial direct current stimulation
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Name: tDCS, direct current stimulation
Placebo Comparator: Sham tDCS
Sham tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds.
 Device: Transcranial direct current stimulation
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Name: tDCS, direct current stimulation
Open-Label Arm
In addition to this study we will have an open label arm in which subjects who received sham stimulation through the course of the study will have the opportunity to receive active stimulation free of charge. The same parameters and identical procedures as is done in the original study will be used. Data will be collected as an open label, which will therefore provide additional information. Data obtained from this open label portion of the study will be kept separate.
 Device: Transcranial direct current stimulation
Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
Other Name: tDCS, direct current stimulation

Detailed Description:

Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical Center - PI - Alvaro Pascual-Leone)

* Further study details are provided by Spaulding Rehabilitation Hospital.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
  • Age 40 or over;
  • Taking stable medications for at least 30 days

Exclusion Criteria:

  • Features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
  • History of deep brain stimulation or ablation surgery, mass brain lesions;
  • History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;
  • Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;

  • Contraindications to tDCS*

    • metal in the head
    • implanted brain medical devices
  • Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease)
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113086

Contacts
Contact: Kayleen M Weaver, BA 617 573 2196 kmweaver@partners.org
Contact: Felipe Fregni, MD 617 573 2326 ffregni@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kayleen M Weaver, BA     617-573-2196     kmweaver@partners.org    
Contact: Felipe Fregni, MD, PhD     617-573-2326     ffregni@partners.org    
Berenson Allen Center for Noninvasive Brain Stimulation Recruiting
Boston, Massachusetts, United States, 02125
Contact: Jennifer Perez, BS     617-667-0226     jperez5@bidmc.harvard.edu    
Contact: Alvaro Pascual-Leone, MD, PhD     (617) 667 - 0203     apleone@bidmc.harvard.edu    
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD, PhD Spaulding Rehabilitation Hospital
Study Chair: Ross Zafonte, DO Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01113086     History of Changes
Other Study ID Numbers: 2009-P-001806
Study First Received: April 20, 2010
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Spaulding Rehabilitation Hospital:
Parkinson
Transcranial direct current stimulation
Motor function
Cognitive function
Affective function

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 24, 2012



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